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From short-term technical assistance to long-term program implementation support and more, AIDSTAR-One provides rapid, evidence-based services to PEPFAR country teams in generalized, mixed and concentrated HIV epidemic settings.

* for children < 3 years † for children ≥ 3 years ‡ for children ≥ 2 years § for children > 6 years

Preferred NRTI combinations:

If failed on AZT or d4T + 3TC switch to:

ABC+3TC

If failed on ABC + 3TC switch to:

AZT+3TC

Alternative NRTI combinations:

If failed on AZT or d4T + 3TC switch to:

ABC+ddI

If failed on ABC + 3TC switch to:

AZT+ddI

Preferred third drug for 2–6 years:

LPV/r or TPV/r

Preferred third drug for > 6 years:

LPV/r or TPV/r or FPV/r or DRV/r or ATV/r* or T20 or RAL

*for children >16 years

In cases of resistance in 3 drug classes (e.g., NRTI, NNRTI, and PI), the decision must be individualized, based on genotypic testing and recent patient medical history. If new classes of medicines are not available, assess off-label use of available drugs or inclusion in a clinical trial.

Burundi

Adults and adolescents 2010

All patients with:

CD4 count < 350/mm3 irrespective of WHO clinical stage;

WHO clinical stage 3 or 4;

TB; or

Hepatitis B coinfection when HBV treatment is indicated

AZT+3TC+NVP;

or

TDF+FTC+EFV

If failed on AZT + 3TC + NVP or EFV switch to:

ABC+TDF+ATV/r or LPV/r

If failed on TDF + FTC + NVP or EFV switch to:

ABC+AZT+ATV/r or LPV/r;

or

ABC+ddI+ATV/r or LPV/r

Any change to third-line treatment should be decided by an expert panel. Choice of drugs would include a new NNRTI, an integrase inhibitor and a new PI/r (e.g., ETV, RAL, or DRV/r).

Burundi

Infants and children 2010

All infants and children < 24 months

Children ≥ 24 to < 59 months with:

CD4% < 25% or CD4 count < 750 mm3; or

WHO pediatric clinical stage 3 or 4

Children > 59 months with:

CD4 count < 350 mm3; or

WHO pediatric clinical stage 3 or 4

Children < 3 years:

AZT+3TC+NVP

Children > 3 years:

AZT+3TC+EFV

ABC+ddI+LPV/r

Any change to third-line treatment should be decided by an expert panel. Choice of drugs would include a new NNRTI, an integrase inhibitor and a new PI/r (e.g., ETV, RAL, or DRV/r).

NVP (for children < 3 and as an alternative for those ≥ 3 who cannot swallow tablets);EFV (for children ≥ 3)

PIs

Preferred:

LPV/r

Alternatives:

FPV/r (for children ≥ 6);ATV/r (for children ≥ 6)

Postpubertal adolescents:

NRTIs:

TDF+3TC

PI/r:

IDV/r or FVP/r or SQV/r or ATV/r

If the first-line regimen was NNRTI-based, change to a PI-based regimen.

If the first-line regimen was PI-based, change to a NNRTI-based regimen or an alternative PI reinforced with a low dose of RTV.

In the case of a new NNRTI-based regimen, it is important to choose a new combination of NRTIs. A resistance test is essential in order to select a combination of NRTIs that the virus is susceptible to. In cases where there are no dual NRTI combinations that the virus is susceptible to, a regimen of 3 distinct classes of ARVs (i.e., NRTI + NNRTI + PI/r) may be indicated.

______

Colombia

Adults and adolescents 2010

All patients with:

CDC category B or C; or

CD4 count < 200/mm3

Consider treating patients with:

CD4 count between 200 and 250/mm3; or

CD4 count between 250 and 350/mm3 and a viral load > 100,000 copies/mL

Preferred:

AZT+3TC+EFV

* In cases where EFV or NVP cannot be used, replace with one of the following PIs: LPV/r or SQV/r or ATV/r or FPV/r

If failed on AZT* or d4T + 3TC + EFV or NVP switch to:

ABC+ddI+FPV±r or LPV/r

If failed on AZT* or d4T + 3TC + PI switch to:

ABC+ddI+EFV or NVP

*AZT is preferred over d4T

Perform genotypic testing on patients with a second or third treatment failure. Always confirm virological failure and a viral load > 1,000 copies/mL before ordering a genotypic test.

Comoros

Adults and adolescents 2007

All patients with:

WHO clinical stage 4;

CD4 count < 200/mm3; or

CD4 count between 200 and 350/mm3 according to clinical and laboratory criteria

TDF+FTC+EFV or NVP

ddI+ABC+EFV or LPV/r

______

Comoros

Infants and children 2007

All patients with:

WHO pediatric clinical stage 3 or 4; or

WHO pediatric clinical stage 1 or 2 and CD4% < 25%

Children ≤ 3 years or ≤ 10 kg:

AZT+3TC+LPV/r

Children > 3 years and > 10 kg:

AZT+3TC+EFV

ddI+ABC+LPV/r

______

Côte d Ivoire

Adults and adolescents 2005

All patients with:

CD4 count < 200/mm3;

CD4 count < 350/mm3and CDC Category B; or

WHO clinical stage 2, 3 or 4 or CDC Category C

d4T or AZT+3TC+NVP or EFV

ABC or TDF+ddI+LPV/r or SQV/r or IDV/r

Refer to specializedhospital

Côte d Ivoire

Infants and children 2005

Children < 18 months with:

WHO pediatric clinical stage 3 or CDC category C irrespective of CD4%; or

WHO pediatric clinical stage 1 or 2 with CD4% < 20%

Children > 18 months with:

CD4% < 15%; or

WHO pediatric clinical stage 3 or CDC category C

d4T or AZT + 3TC + NVP or EFV

ABC+ddI+LPV/r

Refer to specializedhospital

Cuba

Adults and adolescents 2009

All patients with CD4 count < 350/mm3

Patients with special conditions, including:

Viral load > 55,000 copies/mL

Co-morbidities such as Hepatitis B or C, cirrhosis of the liver, or cancer

Drop in a Category based on a decrease in CD4 count or percent within a 3-6 month period

AZT+3TC+NVP (< 3 years) or EFV (> 3 years) or NFV or RTV or LPV/r;

AZT+ddI+NVP (< 3 years) or EFV (> 3 years) or NFV or RTV or LPV/r;

or

d4T+ddI+NVP (< 3 years) or EFV (> 3 years) or NFV or RTV or LPV/r

AZT or d4T+ddI or 3TC+LPV/r or NFV or RTV or NVP or IDV/r or SQV/r

Patients must visita specialized health center.

Ethiopia

Adults and adolescents 2008

All patients with:

CD4 count < 200/mm3;

WHO clinical stage 4; or

CD4 count < 350/mm3 at WHO clinical stage 3

d4T or AZT

+3TC+NVP or EFV;

or

ABC+3TC+AZT

ABC+3TC+LPV/r or ATV/r;

AZT+ABC+LPV/r or ATV/r;

TDF+3TC+LPV/r or ATV/r;

ABC+ddI+LPV/r;

or

EFV or NVP+LPV/r or ATV/r

______

Ethiopia

Infants and children 2008

All infants (< 12 months)

Children from 1–5 years with:

WHO pediatric clinical stage 3 or 4; or

WHO pediatric clinical stage 1 or 2 at CD4% < 20%

Children > 5 years with:

CD4% < 15%

d4T or AZT+3TC+NVP or EFV or LPV/r

ABC+ddI+LPV/r or NFV

______

Ghana

Adults and adolescents 2005

All patients with:

CD4 count < 350/mm3; or

WHO clinical stage 3 or 4

For pregnant women where CD4 count > 350/mm3, initiate ARV prophylaxis at 28 weeks for the purpose of PMTCT.

Preferred drugs, first option:

AZT+3TC+NVP

Preferred drugs, second option:

AZT+3TC+EFV

Alternative drugs, first option:

d4T+3TC+NVP

Alternative drugs, second option:

d4T+3TC+EFV

ABC+ddI+LPV/r or SQV/r or NFV

______

Ghana

Infants and children 2005

Children < 18 months with:

WHO pediatric clinical stage 3 or 4 irrespective of CD4%; or

WHO pediatric clinical stage 2 with CD4% < 20%

Children > 18 months with:

WHO pediatric clinical stage 3 or 4 irrespective of CD4%; or

CD4% < 15%

d4T or AZT+3TC+NVP or EFV

ABC+ddI+SQV/r or NFV

______

Guatemala

Adults and adolescents 2012

All patients with:

AIDS-defining illness;

CD4 count ≤ 350/mm3;

Coinfection with hepatitis B and other clinical conditions associated with HIV that compromise the life of the patient;

≥ 14 months gestation;

TLC < 1200/mm3; or

declining CD4 count > 30% compared to the previous count

First option:

TDF+FTC+EFV or NVP

Second option:

AZT+3TC+EFV or NVP

Third option:

ABC+3TC+EFV or NVP

Adolescents:

Follow pediatric dosing for Tanner stages 1 and 2.

Use individualized dosing for Tanner stage 3.

Follow adult dosing for Tanner stages 4 and 5.

If failed on first option switch to:

ABC+3TC+LPV/r or SQV/r;

ABC+ddI+LPV/r or SQV/r;

or

AZT+ddI+LPV/r or SQV/r

If failed on second option switch to:

ABC+3TC+LPV/r or SQV/r;

or

ABC+ddI+LPV/r or SQV/r

If failed on third option switch to:

ddI+3TC+LPV/r or SQV/r;

TDF + 3TC + LPV/r or SQV/r; or

AZT + ddI + LPV/r or SQV/r

Genotypic testing is required. Consult the recommendations of the Committee on Drug Resistance (Comité de Farmacorresistencia). Patients should continue on second-line treatment until third-line treatment is available.

Patients should be referred to one of the following clinics for treatment before returning to their home clinic:

Clínica de Enfermedades Infecciosas, Hospital Roosevelt

Clínica Familiar Luís Ángel García—ASI

Hospital General San Juan de Dios

Guatemala

Infants and children 2012

All infants (< 12 months)

Children 1–5 years with:

CDC category B or C ;

CD4% < 25%; or

Viral load > 100,000 copies/mL

Children 6–12 years with:

CDC category B or C;

CD4 count < 350/mm3; or

Viral load > 100,000 copies/mL

Children < 3 years or < 10 kg:

First option:

AZT+3TC+NVP or LPV/r

Second option:

ABC+3TC+NVP or LPV/r

Third option:

d4T+3TC+NVP or LPV/r

Children > 3 years or > 10 kg:

First option:

AZT+3TC+NVP or EFV

Second option:

ABC+3TC+NVP or EFV

Third option:

d4T+3TC+NVP or EFV

If failed on first or third option (with EFV or NVP) switch to:

ABC+ddI+LPV/r

If failed on first or third option (with LPV/r) switch to:

ABC+ddI+EFV

If failed on second option (with EFV or NVP) switch to:

AZT+ddI+LPV/r;

or

TDF (if > 16 years)+ABC+LPV/r

If failed on second option (with LPV/r) switch to:

AZT+ddI+EFV;

or

TDF (if > 16 years)+ABC+EFV

Genotypic testing is required. Consult the recommendations of the National Committee on Drug Resistance (Comité de Farmacorresistencia).

Guinea

Adults and adolescents 2011

All patients with:

CD4 count < 350/mm3; or

WHO stage 3 or 4 irrespective of CD4 count

Treatment of patients with CD4 counts between 350 and 500/mm3 should be discussed with regard to:

clinical course;

viral load when available; and

patient motivation

AZT+3TC+NVP or EFV;

TDF+3TC or FTC+EFV;

or

AZT+3TC+LPV/r or ABC

If failed on AZT + 3TC + NVP or EFV switch to:

ABC+ddI+LPV/r (or IDV/r);

or

TDF+FTC+LPV/r (or IDV/r)

If failed on TDF + FTC + EFV switch to:

ABC+ddI+LPV/r (or IDV/r)

If failed on AZT + 3TC + LPV/r switch to:

ABC+ddI+LPV/r (or IDV/r)

Discuss with multidisciplinary team and refer to specialist center. Review treatment history and send for genotypic testing.

2 NRTI+DRV/r+RAL or ETV

Guinea

Infants and children 2011

Infants ≤ 11 months with:

CD4% < 25% or CD4 count < 1500/mm3; or

WHO pediatric clinical stage 3 or 4 irrespective of CD4

Children 12–35 months with:

CD4% < 20% or CD4 count < 750/mm3;

WHO pediatric clinical stage 4 irrespective of CD4; or

WHO pediatric clinical stage 3 irrespective of CD4 count or TLC, but use CD4 as a guide for children with TB, LIP, OHL, or thrombocytopenia

Children 36–59 months with:

CD4% < 15% or CD4 count < 350/mm3;

WHO pediatric clinical stage 4 irrespective of CD4; or

WHO pediatric clinical stage 3 irrespective of CD4 count or TLC, but use CD4 as a guide for children with TB, LIP, OHL, or thrombocytopenia

Children > 5 years with:

CD4% < 15% or CD4 count < 200/mm3;

WHO pediatric clinical stage 4 irrespective of CD4; or

WHO pediatric clinical stage 3 irrespective of CD4 count or TLC, but use CD4 as a guide for children with TB, LIP, OHL, or thrombocytopenia

Third-line ART can sometimes be provided in centers where viral load, genotype, and phenotype testing are available.

Regimens consisting of 5 or more drugs (including 2 PIs), the use of T20, and remaining on the current regimen until other ARVs are available are some of approaches that have been used. In these cases, management is difficult and requires a doctor from a tertiary hospital with sufficient experience in pediatric HIV treatment.

India

Infants and children 2006

Clinical Markers

Infants < 12 months with:

WHO pediatric clinical stage 3 or 4

Children > 12 months with:

WHO pediatric clinical stage 4; or

WHO pediatric clinical stage 3, but use CD4 as a guide for children with TB, LIP, OHL, or thrombocytopenia

Immunological Markers

Infants < 11 months with:

CD4 count < 1500/mm3 (25%)

Children 12–35 months with:

CD4 count < 7500/mm3 (20%)

Children 36–59 months with:

CD4 count < 350/mm3 (15%)

Children > 5 years with:

CD4 count < 200/mm3; or

CD4 count < 350/mm3 at WHO pediatric clinical stage 3

d4T+3TC+NVP or EFV;

or

AZT+3TC+NVP or EFV

If failed on AZT or d4T + 3TC + NVP or EFV switch to:

ddI+ABC+LPV/r or SQV/r or NFV

If failed on ABC or 3TC + NVP or EFV switch to:

ddI+AZT+LPV/r or SQV/r or NFV

If failed on AZT or d4T + 3TC + ABC switch to:

ddI+EFV or NVP+LPV/r or SQV/r or NFV

______

India

Adults and adolescents 2007

All patients with:

CD4 count < 200/mm3; or

WHO clinical stage 4

Those with a CD4 count > 200/mm3 but < 350/mm3 at WHO clinical stage 3 may be considered for treatment.

d4T+3TC+NVP or EFV;

or

AZT+3TC+NVP or EFV

ABC+ddI+LPV/r or SQV/r or NFV

______

Kenya

Adults and adolescents 2011

All patients with:

CD4 count ≤ 350/mm3;

WHO clinical stage 3 or 4;

TB disease;

HIV/hepatitis B coinfection with evidence of active/chronic liver disease; or

HIV-associated nephropathy

TDF+3TC+EFV or NVP

or

AZT+3TC+EFV or NVP

AZT+3TC+LPV/r or ATV/r*;

or

TDF+3TC+LPV/r

* The national therapeutic committee should be consulted for patients who initiated a PI-based regimen as their first-line regimen and subsequently fail treatment.

Maintain the patient on the failing regimen until a full third-line regimen is available as recommended by the national TWG.

Children with such needs should be referred to higher levels of care or ART specialists if necessary.

When salvage treatment is unavailable, a failing second-line regimen may be continued because there is evidence of some benefit despite the emergence of resistance mutations.

Pakistan

Adults and adolescents 2005

If CD4 testing is available:

CD4 count < 200/mm3;

WHO clinical stage 4; or

Consider treatment when CD4 count < 350/mm3 and WHO clinical stage 3

If CD4 testing is not available:

TLC < 1200/mm3 at WHO clinical stage 2; or

WHO clinical stage 3 or 4

AZT+3TC+NVP

TDF or ABC+ddi+NFV

______

Panama

Adults and adolescents 2011

All patients with:

AIDS-defining illness or symptoms of advanced disease;

CD4 count ≤ 350/mm3; or

CD4 count between 350 and 500/mm3 and viral load ≥ 100,000 copies/mL

Preferred:

TDF+3TC or FTC+EFV

Alternative:

AZT+3TC+EFV

For pregnant women:

AZT+3TC+LPV/r;

or

SQV/r

Alternative:

AZT+3TC+NVP

If failed on TDF + 3TC or FTC + EFV switch to:

AZT+ABC or ddI+LPV/r or SQV/r or ATV/r

If failed on AZT + 3TC + EFV switch to:

TDF+ABC+LPV/r or SQV/r or ATV/r

If failed on a PI-based first-line regimen, refer to an infectious disease specialist.

Virologic failure does not always warrant a change in triple therapy. If a regimen change is necessary, it should be done as soon as possible to avoid greater resistance. Patient adherence must be evaluated.

The new regimen should have at least 2 (preferably 3) different active drugs such as RAL or MVC or DRV or EFV.

Panama

Infants and children 2011

All children < 2 years

Children 2 to < 5 years with:

AIDS-defining illness or symptoms of advanced disease; or

CD4% ≤ 25% or CD4 count ≤ 750/mm3 irrespective of symptoms

Consider treatment in children 2 to < 5 years with:

Mild symptoms or asymptomatic;

CD4% ≥ 25%; and

Viral load ≥ 100,000 copies/mL

Children ≥ 5 years with:

AIDS-defining illness or symptoms of advanced disease; or

CD4 count < 350/mm3

Consider treatment in children ≥ 5 years with:

Mild symptoms or asymptomatic;

CD4 count ≥ 350/mm3; and

Viral load ≥ 100,000 copies/mL

Children < 3 years:

AZT+3TC or FTC+LPV/r

Children ≥ 3 years:

AZT+3TC+EFV

Children < 3 years switch to:

AZT+3TC or FTC+NVP

Children ≥ 3 years switch to:

AZT+3TC+LPV/r

______

Papua New Guinea

Adults and adolescents 2009

All patients with:

CD4 count < 350/mm3;

WHO clinical stage 3 or 4 irrespective of CD4; or

WHO clinical stage 2 with TLC < 1200/mm3

AZT+3TC+NVP or EFV;

or

d4T+3TC+NVP or EFV

If failed on AZT + 3TC + NVP or EFV switch to:

TDF or ddI+ABC+LPV/r or SQV/r

If failed on d4T + 3TC + NVP switch to:

TDF+ABC+LPV/r

If failed on d4T + 3TC + EFV switch to:

ddI+ABC+SQV/r

If failed on d4T + 3TC + EFV switch to:

TDF+ABC+SQV/r

______

Papua New Guinea

Infants and children 2009

All infants < 12 months

Children 12–35 months with:

CD4% < 20% or CD4 count < 750/mm3;

TLC < 3000/mm3;

WHO pediatric clinical stage 4; or

WHO pediatric clinical stage 3 guided by CD4 in those with OHL, LIP, TB, or thrombocytopenia

Children 36–59 months with:

CD4% < 20% or CD4 count < 350/mm3;

TLC < 2500/mm3;

WHO pediatric clinical stage 4; or

WHO pediatric clinical stage 3 guided by CD4 in those with OHL, LIP, TB, or thrombocytopenia

Children ≥ 5 years with:

CD4% < 15% or CD4 count < 350/mm3;

TLC < 2000/mm3;

WHO pediatric clinical stage 4; or

WHO pediatric clinical stage 3 guided by CD4 in those with OHL, LIP, TB, or thrombocytopenia

WHO pediatric clinical stage 3 irrespective of CD4 count, but use CD4 as a guide for children > 12 months with TB, LIP, OHL, or thrombocytopenia; or

WHO pediatric clinical stage 1 or 2 and CD4 or TLC value at or below the threshold

If virological testing is not available to confirm HIV infection, HIV antibody–positive infants and children < 18 months who have clinically diagnosed presumed severe HIV disease should be considered for ART.

Children < 3 years or < 10 kg:

AZT+3TC+NVP;

or

d4T+3TC+NVP

Children > 3 years and > 10 kg:

AZT+3TC+EFV or NVP;

or

d4T+3TC+EFV or NVP

If failed on AZT + 3TC backbone switch to:

d4t+ddI

If failed on d4T + 3TC backbone switch to:

AZT+ddI

If failed on EFV or NVP switch to:

Switch third drug to LPV/r

If failed on LPV/r switch to:

Switch third drug to EFV or NVP

______

South Africa

Adults and adolescents 2010

All patients with:

CD4 count ≤ 200/mm3;

WHO clinical stage 4;

CD4 count ≤ 350/mm3and coinfected with TB; or

MDR or XDR TB

TDF+3TC or FTC+EFV or NVP

AZT+3TC+LPV/r

______

South Africa

Infants and children 2010

All infants (< 12 months)

Children 12 months to 5 years with:

CD4% ≤ 25% (750/mm3); or

WHO pediatric clinical stage 3 or 4

Children > 5 years with:

CD4 count < 350/mm3; or

WHO pediatric clinical stage 3 or 4

Children < 3 years of age or weighing < 10kg:

ABC+3TC+LPV/r

Children > 3 years and weighing > 10kg:

ABC+3TC+EFV

______

______

Swaziland

Infants and children 2006

All children with:

WHO pediatric clinical stage 3 or 4 irrespective of CD4 count or percentage; or

WHO pediatric clinical stage 1 or 2, if the CD4 immunological stage is “severe”

d4T or AZT+3TC+NVP

ABC+ddI+LPV/r

______

Swaziland

Adults and adolescents 2010

All patients with:

CD4 count < 350/mm3;

WHO clinical stage 3 or 4;

Any form of TB, especially drug-resistant TB;

Hepatitis B coinfection; or

HIV-associated nephropathy

Preferred NRTI backbone:

TDF+3TC

Alternative:

AZT or d4+3TC

Preferred NNRTI:

EFV

Alternative:

NVP

ABC+ddI+LPV/r*

* Use SQV/r or ATV/r or IDV/r in patients who cannot tolerate LPV/r.

______

Tanzania

Adults and adolescents 2009

All patients with:

WHO clinical stage 4 irrespective of CD4 count;

CD4 count ≤ 200/mm3 irrespective of WHO clinical stage; or

CD4 count between 200 and 350/mm3 at WHO clinical stage 3

AZT+3TC+EFV

Alternatives to AZT:

d4T or TDF

Alternative to 3TC:

FTC

If failed on AZT or d4t switch to:

TDF+3TC or FTC+LPV/r or ATV/r

If initiated on TDF due to intolerance to AZT or d4T switch to:

ABC+ddI+LPV/r or ATV/r

ART regimen should be continued until patient is no longer receiving clinical benefits from treatment.

If the patient is at WHO clinical stage 4 while on second-line regimen, expert opinion should be sought regarding stopping ART and instituting palliative care.

Children who have received NVP or 3TC as MTCT prophylaxis should be given a second-line PI-based regimen. If second-line regimen is unavailable, these children should be given an available first-line regimen.

ddI+ABC+LPV/r or NFV

______

Thailand

Adults and adolescents 2010

All patients with:

CD4 count ≤ 350/mm3;

AIDS-defining illness;

HIV-related symptoms; or

Pregnant women*

* But discontinue after delivery for those women with a pretreatment CD4 count of ≥ 350/mm3

Preferred:

AZT+3TC+EFV or NVP;

or

TDF+3TC or FTC+EFV or NVP

Alternatives:

ABC+3TC+EFV;

d4T*+3TC+EFV or NVP;

or

ddI+3TC+EFV or NVP

* d4T should be replaced by another NRTI after 6–12 months.

If patient cannot tolerate NNRTIs, replace with:

Preferred:

LPV/r

Alternative:

ATV/r or DRV/r or SQV/r

If first regimen was NNRTI-based switch to:

PI/r+2 active NRTIs indicated by genotypic testing

If first regimen was PI/r-based switch to:

Active PI/r+2 active NRTIs indicated by genotypic testing;

Active PI/r+1 NNRTI ± 1 NRTI indicated by genotypic testing; or

NNRTI+2 active NRTIs indicated by genotypic testing

At least 2 new active ARVs, such as DRV/r or ETV or RAL

Refer to expert consultation or appropriate clinical trial in cases where these drugs are not available. While waiting for new drugs, a holding regimen consisting of 3TC and other NRTIs may be considered.

Thailand

Infants and children 2010

All infants (< 12 months)

Children 1–5 years with:

CD4% < 25%;

WHO pediatric clinical stage 3 or 4; or

CDC category B or C

Children > 5 years with:

CD4 count < 350/mm3;

WHO pediatric clinical stage 3 or 4; or

CDC category B or C

Children < 3 years:

Preferred:

AZT+3TC+NVP

Alternative:

d4T+3TC+NVP

Children > 3 years:

Preferred:

AZT+3TC+EFV

Alternative:

AZT+3TC+NVP;

or

d4T+3TC+EFV or NVP

Adolescents (weight > 40kg or Tanner stage 4):

TDF+3TC+EFV

2 NRTIs+PI/r

Select NRTIs guided by genotype of RT gene. Refer to Figure 1 on page 510 of the guidelines for specific second-line regimens recommended for different scenarios.

To design a salvage regimen, use at least 2 active drugs plus a recycled NRTI. Access to new drugs such as DRV, MVC, ETV, and RAL may be needed. Expert consultation is recommended. Refer to page 511 of the guidelines for further information.

A combination of 2 PIs (except for TPV, which is not recommended in combination with other PIs)

Ukraine

Infants and children 2007

Infants ≤ 11 months:

CD4% ≤ 25% (CD4 count ≤ 1500/mm3); or

WHO pediatric clinical stage 3 or 4

Children 12–35 months:

CD4% ≤ 20% (750/mm3);

WHO pediatric clinical stage 4; or

WHO pediatric clinical stage 3 with specific OIs*

Children 36–59 months:

CD4% ≤ 15% (350/mm3);

WHO pediatric clinical stage 4; or

WHO pediatric clinical stage 3 with specific OIs*

Children ≥ 5 years:

CD4% ≤ 15% (200/mm3);

WHO pediatric clinical stage 4; or

WHO pediatric clinical stage 3 with specific OIs*

* TB, LIP, OHL, or thrombocytopenia

Preferred NRTI backbones:

AZT+3TC;

d4T+3TC;

AZT+ddI;

or

ddI+3TC

Alternative NRTI backbones:

ABC+AZT;

ABC+3TC;

or

d4T+ddI

NNRTIs:

Children < 3 years:

NVP

Children ≥ 3 years:

EFV

PIs:

LPV/r or NFV

If failed on AZT or d4T + 3TC + NVP or EFV switch to:

ddI+ABC+LPV/r or SQV/r or NFV

If failed on ABC + 3TC + NVP or EFV switch to:

ddI+AZT+LPV/r or SQV/r or NFV

If failed on AZT or d4T + 3TC + LPV/r or NFV switch to:

ddI+ABC+LPV/r or EFV or NVP

If failed on ABC + 3TC + LPV/r or NFV switch to:

ddI+AZT+LPV/r or EFV or NVP

If failed on AZT or d4T + 3TC + ABC switch to:

ddI+EFV or NVP+LPV/r or SQV/r or NFV

This requires consultation with an experienced professional.

Strategic approaches include:

T20

Reuse of ARVs

Structured treatment interruption

The continuation of current therapy until appropriate drugs are available

United States

Adults and adolescents 2012

All patients with:

CD4 count ≤ 500/mm3;

Pregnancy

History of an AIDS-defining illness;

HIV-associated nephropathy; or

Hepatitis B co-infection

Preferred:

EFV+TDF+ FTC;

or

ATV/r or DRV/r or RAL+TDF + FTC

Patient’s treatment history and former and current resistance test results should be used to identify at least 2 (preferably 3) fully active agents to combine with an optimized background ARV regimen. Refer to the guidelines for further guidance (pg. H-1).

Refer to pg. H-1 of the guidelines.

United States

Infants and children 2010

All infants (< 12 months)

Children ≥ 1 with:

AIDS or significant symptoms (CDC category C or most category B conditions); or

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